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Syringe Atr Inflation Hp

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
SYRINGE ATR INFLATION HP FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
SYRINGE A08E-ATR INFLATION HP FDA UDI
Model / Reference
A08E-ATR FDA UDI
Description
SYRINGE A08E-ATR INFLATION HP FDA UDI

Identifiers

Primary DI / UDI-DI
00763000557065 FDA UDI
510(k) Number
K020333 FDA UDI
K994253 FDA UDI
FDA Product Code
DXT FDA UDI
FMF FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
880.5860 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

Syringe Atr Inflation Hp by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Cleared under the same submission

K994253 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 87ea10e3-43de-40f6-a647-86bbac16a2c0 36 fields · synced Jun 1, 2026