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Monoglyc

FDA UDI

Class II (US FDA UDI)

by Resorba Medical GmbH

Identity

Trade Name
MONOGLYC FDA UDI
Generic Name
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI
Model / Reference
MONOGLYC FDA UDI

Identifiers

Primary DI / UDI-DI
E203JCG61506 FDA UDI
E203JCG61412 FDA UDI
E203JCG60230 FDA UDI
E203JCG65121 FDA UDI
E203JCG61512 FDA UDI
E203JCG60216 FDA UDI
E203JCG60606 FDA UDI
E203JCG61515 FDA UDI
E203JCG60203 FDA UDI
E203JCG61101 FDA UDI
E203JCG61510 FDA UDI
E203JCG65127 FDA UDI
E203JCG60605 FDA UDI
510(k) Number
K143584 FDA UDI
FDA Product Code
GAM FDA UDI
GMDN Term
Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Polyester suture, bioabsorbable, multifilament, non-antimicrobial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4493 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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: Polyester suture, bioabsorbable, monofilament, non-antimicrobial

Monoglyc by Resorba Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.

Cleared under the same submission

K143584 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Resorba Medical GmbH

Sources (13)

  • FDA UDI 24b56d75-5b61-48da-9a4b-b074762bccfb 33 fields · synced Jun 6, 2026
  • FDA UDI d66cca8e-d376-4539-a181-5778ec226a25 33 fields · synced May 24, 2026
  • FDA UDI 7989aa4e-3cbc-4154-b499-9d5aa2e1d4ee 33 fields · synced May 24, 2026
  • FDA UDI b015866e-5ad9-44c5-a4e4-b473808420e1 33 fields · synced May 24, 2026
  • FDA UDI 7ea8c28e-b06b-4379-85d7-e382f28a0b52 33 fields · synced May 25, 2026
  • FDA UDI 8430890c-0b4d-435a-8503-022292fe3ce1 33 fields · synced May 25, 2026
  • FDA UDI 3b6999a3-0166-444a-ad33-7d004e99e96a 33 fields · synced May 25, 2026
  • FDA UDI e5633171-91c9-493c-899c-014343232b38 33 fields · synced May 25, 2026
  • FDA UDI b77a53d6-692f-4daf-b117-26acce7e2d7d 33 fields · synced May 25, 2026
  • FDA UDI e83fd205-bd9f-4faf-950f-183bc41fe29a 33 fields · synced May 26, 2026
  • FDA UDI 5074e3ff-e432-4c54-ab32-3b65d98794ce 33 fields · synced May 26, 2026
  • FDA UDI 32597b55-3279-41f6-a7bd-2786e621364b 33 fields · synced May 27, 2026
  • FDA UDI 310ebf01-b535-4449-9b75-c530c2fa9d01 33 fields · synced May 27, 2026