← Back to catalogue

BOSS Instruments

FDA UDI

Class I (US FDA UDI)

by Boss Instruments, Ltd.

Identity

Trade Name
BOSS Instruments FDA UDI
Generic Name
Orthodontic palate expander/teeth aligner, self-removable FDA UDI
Device Name
Tessier Graft Site Expander, 6 3/4" (17cm) FDA UDI
Model / Reference
85-1140 FDA UDI
Description
Tessier Graft Site Expander, 6 3/4" (17cm) FDA UDI

Identifiers

Catalog Number
85-1140 FDA UDI
Primary DI / UDI-DI
00888515225169 FDA UDI
FDA Product Code
EIG FDA UDI
GMDN Term
Orthodontic palate expander/teeth aligner, self-removable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic palate expander/teeth aligner, self-removable

BOSS Instruments by Boss Instruments, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic palate expander/teeth aligner, self-removable.

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
Boss Instruments, Ltd.

Sources (1)

  • FDA UDI 8abf87b4-2286-41b5-9b55-0c6271da9bbe 35 fields · synced Jun 9, 2026