Primary Device ID | 03701037313107 |
NIH Device Record Key | 3268243f-3a39-42c2-abb4-1e6411891928 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Version Model Number | 913-0718 |
Catalog Number | 913-0718 |
Company DUNS | 263076196 |
Company Name | FX SOLUTIONS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Special Storage Condition, Specify | Between 0 and 0 *Store away from light and sunlight Store away from moisture |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03701037313107 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
[03701037313107]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-10-08 |
Device Publish Date | 2020-05-20 |
03701037313558 | STABILITY TRIAL CUP FOR BOACH Ø32 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313541 | STABILITY TRIAL CUP FOR BOACH Ø32 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313534 | STABILITY TRIAL CUP FOR BOACH Ø32 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313527 | STABILITY TRIAL CUP FOR BOACH Ø32+9 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313510 | STABILITY TRIAL CUP FOR BOACH Ø32+6 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313503 | STABILITY TRIAL CUP FOR BOACH Ø32+3 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313497 | STABILITY TRIAL CUP Ø40 + 18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313480 | STABILITY TRIAL CUP Ø40 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313473 | STABILITY TRIAL CUP Ø40 + 12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313466 | STABILITY TRIAL CUP Ø36 + 18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313459 | STABILITY TRIAL CUP Ø36 + 15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313442 | STABILITY TRIAL CUP Ø36 + 12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313138 | STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313121 | STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313114 | STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313107 | STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313091 | STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313084 | STANDARD TRIAL HUMERAL CUP 135/145° Ø36 +12 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313077 | STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +18 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313060 | STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +15 |
03701037313053 | STANDARD TRIAL HUMERAL CUP 135/145° Ø32 +12 |
03701037312735 | GLENOID RESURFACING REAMER Ø43 mm / FX |
03701037312179 | SPIKED PROTECTOR Ø 41mm |
03701037312162 | SPIKED PROTECTOR Ø 46mm |
03701037317723 | HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE L |
03701037317716 | HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE M |
03701037317709 | HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE S |
03701037317693 | HOLLOW GLENOID K-WIRE GUIDE + TEMPLATE SIZE XS |
03701037317686 | 40/16 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317679 | 40/14 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317662 | 40/12 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317655 | 36/14 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317648 | 36/12 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317631 | 36/10 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317624 | 32/12 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317617 | 32/10 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317600 | 32/08 HUMELOCK REVERSED BROACH WITH RADIUS |
03701037317594 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +18 |
03701037317587 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +15 |
03701037317570 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +12 |
03701037317563 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +9 |
03701037317556 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +6 |
03701037317549 | STANDARD TRIAL FIXED CUP FOR BROACH Ø40 +3 |
03701037317532 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +18 |
03701037317525 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +15 |
03701037317518 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +12 |
03701037317501 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +9 |
03701037317495 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +6 |
03701037317488 | STANDARD TRIAL FIXED CUP FOR BROACH Ø36 +3 |
03701037317471 | STANDARD TRIAL FIXED CUP FOR BROACH Ø32 +18 |