McKesson.

GUDID 20612479189137

Speculum, Vaginal, Non-Metal

MCKESSON MEDICAL-SURGICAL INC.

Vaginal speculum, single-use Vaginal speculum, single-use

• Primary Device ID: 20612479189137
• NIH Device Record Key: 62c9e6cb-e227-4a04-b1d9-51c2ed266e06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: McKesson.
• Version Model Number: 211
• Company DUNS: 023904428
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10612479218175 [Unit of Use]
GS1	20612479189137 [Primary]
GS1	40612479189148 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050887

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-09

Devices Manufactured by MCKESSON MEDICAL-SURGICAL INC.

• 00612479270978 - McKesson: 2024-04-25 Isolation Gown, Tape tab neck, waist tie, Yellow, SMS, Non-sterile, OSFM
• 00612479271005 - McKesson: 2024-04-25 Isolation Gown, Tape tab neck, waist tie, Yellow, SMS, Non-sterile, XL
• 00612479271036 - McKesson: 2024-04-25 Isolation Gown, neck and waist tie, Yellow, SMS, Non-sterile, OSFM
• 00612479271067 - McKesson: 2024-04-25 Isolation Gown, neck and waist tie, Yellow, SMS, Non-sterile, XL
• 00612479271098 - McKesson: 2024-04-25 SMS NR Isolation gown Blue, OSFM
• 00612479271128 - McKesson: 2024-04-25 SMS NR Isolation gown Blue, XL
• 00612479271159 - McKesson: 2024-04-25 Spunbond Polypropylene NR Isolation gown w/ elastic wrist, full back -OSFM
• 00612479271180 - McKesson: 2024-04-25 Spunbond Polypropylene NR Isolation gown w/ elastic wrist, full back -XL