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Customed

FDA UDI

Class I (US FDA UDI)

by Customed, Inc.

Identity

Trade Name
CUSTOMED FDA UDI
Generic Name
Obstetrical/gynaecological surgical procedure kit, medicated FDA UDI
Device Name
OB SURGICAL PACK HOSPITAL SAN CRISTOBAL FDA UDI
Model / Reference
712057200012 FDA UDI
Description
OB SURGICAL PACK HOSPITAL SAN CRISTOBAL FDA UDI

Identifiers

Catalog Number
900012 FDA UDI
Primary DI / UDI-DI
M2089000120 FDA UDI
510(k) Number
K902271 FDA UDI
FDA Product Code
HHD FDA UDI
GMDN Term
Obstetrical/gynaecological surgical procedure kit, medicated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.5435 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Obstetrical/gynaecological surgical procedure kit, medicated

Customed by Customed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Obstetrical/gynaecological surgical procedure kit, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Customed, Inc.

Sources (1)

  • FDA UDI 08ea62cb-13c9-4349-8c71-04216eb04b2c 37 fields · synced May 31, 2026