Identity
- Trade Name
- Colorectal Air Syringe-LP FDA UDI
- Generic Name
- Endoscope inflation bulb FDA UDI
- Device Name
- Expedite and standardize the 'bubble test' for colorectal anastomoses. FDA UDI
- Model / Reference
- ALT-50 FDA UDI
- Description
- Expedite and standardize the 'bubble test' for colorectal anastomoses. FDA UDI
Identifiers
- Catalog Number
- ALT-50 FDA UDI
- Primary DI / UDI-DI
- 00861838000361 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Endoscope inflation bulb 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8.7 Inch FDA UDI
Category: Endoscope inflation bulb
Colorectal Air Syringe-LP by Tools For Surgery, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope inflation bulb.
- DOUBLE INSUFFLATION BULB — Heine Optotechnik GmbH & Co. KG · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Disposable Bulb & Bladder — HEALTHMARK INDUSTRIES CO., INC. · Class I
- FLY — Shanghai FLY Medical Devices Co., Ltd. · Class I
- Sterile Bulb & Bladder — HEALTHMARK INDUSTRIES CO., INC. · Class I
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Bariatric Air Syringe — TOOLS FOR SURGERY, LLC · Class I
- Colorectal Air Syringe-LP EX — TOOLS FOR SURGERY, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tools For Surgery, Llc
Sources (1)
- FDA UDI 3f9cd4eb-dd9f-4714-9906-048cc7a896d7 36 fields · synced May 30, 2026