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Batrik Bitestrong Bite Blocks

FDA UDI

Class I (US FDA UDI)

by Batrik Medical Manufacturing Inc

Identity

Trade Name
Batrik Bitestrong Bite Blocks FDA UDI
Generic Name
Endoscopic bite block, basic, single-use FDA UDI
Device Name
Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, Reusable, with strap FDA UDI
Model / Reference
BO2-R FDA UDI
Description
Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, Reusable, with strap FDA UDI

Identifiers

Catalog Number
BO2-R FDA UDI
Primary DI / UDI-DI
00690521000148 FDA UDI
FDA Product Code
MNK FDA UDI
GMDN Term
Endoscopic bite block, basic, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Endoscopic bite block, basic, single-use

Batrik Bitestrong Bite Blocks by Batrik Medical Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic bite block, basic, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Batrik Medical Manufacturing Inc

Sources (1)

  • FDA UDI 66173178-ac74-4590-a6cc-b3a0516df538 36 fields · synced Jun 8, 2026