Primary Device ID | M8030K22008 |
NIH Device Record Key | 2d5bc05a-9261-4dcf-aac7-08343c2f3673 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MedGyn Flexible/Karman Cannula-Curette 8mm |
Version Model Number | 8mm Flexible/Karman Curette |
Catalog Number | 022008K |
Company DUNS | 103913430 |
Company Name | MEDGYN PRODUCTS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M8030K22008 [Primary] |
HCY | Curette, Uterine |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-25 |
Device Publish Date | 2025-04-17 |
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M803030906 - Pederson Small | 2025-06-03 Pederson Small 1/2" x 3" (13mm x 76mm) |
M803030907 - Pederson Medium | 2025-06-03 Pederson Medium 7/8" x 4" (22mm x 102mm) |
M803030908 - Pederson Large | 2025-06-03 Pederson Large 1" x 4 3/4" (25mm x 121mm) |
M803030910 - Graves Wide Angled Medium Right Side Open | 2025-06-03 Graves Wide Angled Medium Right Side Open 1 3/8" x 4" (35mm x 102mm) |
M803030911 - Weisman Graves Medium - Right Side Open | 2025-06-03 Weisman Graves Medium - Right Side Open 1 3/8" x 4" (35mm x 102mm) |
M803030912 - Weisman Graves Medium | 2025-06-03 Weisman Graves Medium - Left Side Open 1 3/8" x 4" (35mm x 102mm) |
M803030913 - Pederson XSmall | 2025-06-03 Pederson XSmall 1/2" x 2 3/4" (13mm x 70mm) |