Primary Device ID | 00817489026267 |
NIH Device Record Key | 14abda6b-66b8-46cf-af71-52aeb566e5ae |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Disposable Iris Retractor Hooks |
Version Model Number | D4176-5 |
Company DUNS | 007883297 |
Company Name | KATALYST SURGICAL LLC |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817489026267 [Primary] |
GS1 | 10817489026264 [Package] Package: Pack of Hooks [5 Units] In Commercial Distribution |
GS1 | 20817489026261 [Package] Package: Pack of Hooks [2 Units] In Commercial Distribution |
HNI | Retractor, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-05-06 |
Device Publish Date | 2025-04-28 |
00817489026267 - Disposable Iris Retractor Hooks | 2025-05-06Disposable Iris Retractor Hooks |
00817489026267 - Disposable Iris Retractor Hooks | 2025-05-06 Disposable Iris Retractor Hooks |
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