Primary Device ID | 00849771046370 |
NIH Device Record Key | b7677374-aea9-49b6-b6e1-9501242d5e10 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | K-Wire and Steinmann Pin Dispensers |
Version Model Number | KI71046 |
Catalog Number | KI71046 |
Company DUNS | 604056226 |
Company Name | KEY SURGICAL, INC. |
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 | false |
OTC Over-The-Counter | false |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com | |
Phone | +1(800)541-7995 |
regulatory@keysurgical.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00849771046370 [Primary] |
MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00849771046370]
Moist Heat or Steam Sterilization
[00849771046370]
Moist Heat or Steam Sterilization
[00849771046370]
Moist Heat or Steam Sterilization
[00849771046370]
Moist Heat or Steam Sterilization
[00849771046370]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-24 |
Device Publish Date | 2025-04-16 |
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00849771046394 | K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 26 |
00849771046387 | K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25 |
00849771046370 | K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24 |
00849771046363 | K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22 |