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Gyrus ACMI

FDA UDI

Class I (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Gyrus ACMI FDA UDI
Generic Name
Intranasal splint, non-bioabsorbable, animal-derived FDA UDI
Device Name
Blu Glide B-Style Sinus Pack, Slim, 2.5 cm x .6 cm x 2.0 cm, Bacteriostatic FDA UDI
Model / Reference
7089-0853 FDA UDI
Description
Blu Glide B-Style Sinus Pack, Slim, 2.5 cm x .6 cm x 2.0 cm, Bacteriostatic FDA UDI

Identifiers

Primary DI / UDI-DI
00821925037380 FDA UDI
510(k) Number
K983276 FDA UDI
FDA Product Code
EMX FDA UDI
GMDN Term
Intranasal splint, non-bioabsorbable, animal-derived FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4100 FDA UDI
Commercial Distribution
Not 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

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

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

Cleared under the same submission

K983276 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI c7c2d8e5-cfb8-49ff-b34c-1949fd3b2a56 35 fields · synced May 31, 2026