Primary Device ID | 00840606165662 |
NIH Device Record Key | d65c3218-64d9-408e-85d3-57cb305ed97a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SAPPHIRE |
Version Model Number | 26000-002-35 |
Company DUNS | 610712213 |
Company Name | SPINAL ELEMENTS, 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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840606165662 [Primary] |
OJH | Orthopedic Tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
[00840606165662]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-05 |
Device Publish Date | 2021-04-27 |
00840606108072 | Dia. 4.5 x 11mm Self-Tapping Variable-Angle Screw |
00840606108065 | Dia. 4.5 x 10mm Self-Tapping Variable-Angle Screw |
00840606108058 | Dia. 4.0 x 20mm Self-Tapping Variable-Angle Screw |
00840606107976 | Dia. 4.0 x 12mm Self-Tapping Variable-Angle Screw |
00840606107921 | Ø4.0MM x 18MM FIXED-ANGLE SELF DRILLING SCREW |
00840606107204 | 2-LEVEL, 38MM ANTERIOR CERVICAL PLATE |
00840606107198 | 2-LEVEL, 35MM ANTERIOR CERVICAL PLATE |
00840606107181 | 2-LEVEL, 32MM ANTERIOR CERVICAL PLATE |
00840606107174 | 2-LEVEL, 29MM ANTERIOR CERVICAL PLATE |
00840606107167 | 2-LEVEL, 26MM ANTERIOR CERVICAL PLATE |
00840606107150 | 1-LEVEL, 25MM ANTERIOR CERVICAL PLATE |
00840606107143 | 1-LEVEL, 23MM ANTERIOR CERVICAL PLATE |
00840606107136 | 1-LEVEL, 21MM ANTERIOR CERVICAL PLATE |
00840606107129 | 1-LEVEL, 19MM ANTERIOR CERVICAL PLATE |
00840606107112 | 1-LEVEL, 17MM ANTERIOR CERVICAL PLATE |
00840606107105 | 1-LEVEL, 15MM ANTERIOR CERVICAL PLATE |
00840606107099 | 1-LEVEL, 13MM ANTERIOR CERVICAL PLATE |
00840606107082 | 1-LEVEL, 11MM ANTERIOR CERVICAL PLATE |
00840606108317 | Dia. 4.5 x 13mm Self-Tapping Fixed-Angle Screw |
00840606108300 | Dia. 4.5 x 12mm Self-Tapping Fixed-Angle Screw |
00840606108294 | Dia. 4.5 x 11mm Self-Tapping Fixed-Angle Screw |
00840606108287 | Dia. 4.5 x 10mm Self-Tapping Fixed-Angle Screw |
00840606108270 | Dia. 4.0 x 20mm Self-Tapping Fixed-Angle Screw |
00840606108263 | Dia. 4.0 x 19mm Self-Tapping Fixed-Angle Screw |
00840606108256 | Dia. 4.0 x 18mm Self-Tapping Fixed-Angle Screw |
00840606108249 | Dia. 4.0 x 17mm Self-Tapping Fixed-Angle Screw |
00840606108232 | Dia. 4.0 x 16mm Self-Tapping Fixed-Angle Screw |
00840606108225 | Dia. 4.0 x 15mm Self-Tapping Fixed-Angle Screw |
00840606108218 | Dia. 4.0 x 14mm Self-Tapping Fixed-Angle Screw |
00840606108201 | Dia. 4.0 x 13mm Self-Tapping Fixed-Angle Screw |
00840606108195 | Dia. 4.0 x 12mm Self-Tapping Fixed-Angle Screw |
00840606108171 | Dia. 4.0 x 10mm Self-Tapping Fixed-Angle Screw |
00840606108164 | Dia. 4.5 x 20mm Self-Tapping Variable-Angle Screw |
00840606108157 | Dia. 4.5 x 19mm Self-Tapping Variable-Angle Screw |
00840606108140 | Dia. 4.5 x 18mm Self-Tapping Variable-Angle Screw |
00840606108133 | Dia. 4.5 x 17mm Self-Tapping Variable-Angle Screw |
00840606108126 | Dia. 4.5 x 16mm Self-Tapping Variable-Angle Screw |
00840606108119 | Dia. 4.5 x 15mm Self-Tapping Variable-Angle Screw |
00840606108102 | Dia. 4.5 x 14mm Self-Tapping Variable-Angle Screw |
00840606108096 | Dia. 4.5 x 13mm Self-Tapping Variable-Angle Screw |
00840606108089 | Dia. 4.5 x 12mm Self-Tapping Variable-Angle Screw |
00840606108041 | Dia. 4.0 x 19mm Self-Tapping Variable-Angle Screw |
00840606108034 | Dia. 4.0 x 18mm Self-Tapping Variable-Angle Screw |
00840606108027 | Dia. 4.0 x 17mm Self-Tapping Variable-Angle Screw |
00840606108010 | Dia. 4.0 x 16mm Self-Tapping Variable-Angle Screw |
00840606108003 | Dia. 4.0 x 15mm Self-Tapping Variable-Angle Screw |
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00840606107983 | Dia. 4.0 x 13mm Self-Tapping Variable-Angle Screw |
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