Hawkin Ambler 16pc Dilator Set 030780

GUDID M803030780

Hawkin Ambler 16pc Dilator Set 3-6mm - 18-21mm

MEDGYN PRODUCTS, INC.

Fixed-diameter cervical dilator, reusable
Primary Device IDM803030780
NIH Device Record Key535de2e9-64d8-44ce-9c3a-bd74124b0e91
Commercial Distribution StatusIn Commercial Distribution
Brand NameHawkin Ambler 16pc Dilator Set
Version Model NumberHawkin Ambler 16pc Dilator Set 3-6mm - 18-21mm
Catalog Number030780
Company DUNS103913430
Company NameMEDGYN PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM803030780 [Primary]

FDA Product Code

HDQDilator, Cervical, Fixed Size

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


[M803030780]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-25
Device Publish Date2025-04-17

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