McKesson.

GUDID 20612479189137

Speculum, Vaginal, Non-Metal

MCKESSON MEDICAL-SURGICAL INC.

Vaginal speculum, single-use
Primary Device ID20612479189137
NIH Device Record Key62c9e6cb-e227-4a04-b1d9-51c2ed266e06
Commercial Distribution StatusIn Commercial Distribution
Brand NameMcKesson.
Version Model Number211
Company DUNS023904428
Company NameMCKESSON MEDICAL-SURGICAL INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110612479218175 [Unit of Use]
GS120612479189137 [Primary]
GS140612479189148 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIBSpeculum, Vaginal, Nonmetal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-09

Devices Manufactured by MCKESSON MEDICAL-SURGICAL INC.

40612479135244 - McKesson2024-11-07 Non-Woven Sponge, Non-Sterile, 4" x 4", High Absorbency, 4-Ply
10612479206943 - McKesson2024-10-21 Syringe, LL 30cc
10612479217284 - McKesson2024-10-21 Syringe, LL 1cc
00612479269484 - McKesson2024-09-17 STARTER KIT, CURETTE EAR LIGHTED COMPLETE RECHARGEABLE
00612479269491 - McKesson2024-09-17 LIGHT SOURCE, EAR CURETTE
00612479269514 - McKesson2024-09-17 CHARGER, EAR LIGHTED CURETTE
00612479269545 - McKesson2024-09-17 CURETTE, EAR LIGHTED #1 OVAL LOOP (50/BX)
00612479269576 - McKesson2024-09-17 CURETTE, EAR LIGHTED #2 SM SPOON (50/BX

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