Primary Device ID | M803030872 |
NIH Device Record Key | d97a517f-a813-49b6-8c79-e0b0e3236e93 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pratt Dilator Extra Large |
Version Model Number | Pratt Dilator Extra Large 49-51 Fr (16.3-17 mm) |
Catalog Number | 030872 |
Company DUNS | 103913430 |
Company Name | MEDGYN PRODUCTS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | MR Unsafe |
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 |
---|---|
HIBCC | M803030872 [Primary] |
HDQ | Dilator, Cervical, Fixed Size |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
[M803030872]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-25 |
Device Publish Date | 2025-04-17 |
M803030879 | Pratt Dilator Extra Large 77-79 Fr (25.6-26.3 mm) |
M803030877 | Pratt Dilator Extra Large 69-71 Fr (23-23.6 mm) |
M803030876 | Pratt Dilator Extra Large 65-67 Fr (21.6-22.3 mm) |
M803030875 | Pratt Dilator Extra Large 61-63 Fr (20.3-21 mm) |
M803030874 | Pratt Dilator Extra Large 57-59 Fr (19-19.6 mm) |
M803030873 | Pratt Dilator Extra Large 53-55 Fr (17.6-18.3 mm) |
M803030872 | Pratt Dilator Extra Large 49-51 Fr (16.3-17 mm) |
M803030871 | Pratt Dilator Extra Large 45-47 Fr (15-15.6 mm) |