FDA.report

Boss Instruments

Primary DI
00888515110830
Brand
Boss Instruments
Company
BOSS INSTRUMENTS, LTD., INC.
Model
65-6371
Catalog number
65-6371
Device description
Debakey Derra Anastomosis Clamp, 6 1/2", med jaw
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DXCCLAMP, VASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888515110830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888515110830008885151108308885151108300888515110830

GMDN Terms

TermDefinition
Vascular anastomosis clampA surgical instrument used to perform a vascular anastamosis (surgical communication between two or more veins or arteries) by compressing the vessels to ensure haemostasis (arrest or prevention of bleeding) before the procedure. It is typically self-retaining and has a scissors-like design with ring handles and blades of various designs (e.g., curved, angled, or semicircular) at the working end, or it may be designed with levers that are locked into position at the site of intervention. It is typically made of high-grade stainless steel and may utilize carbide inserts; it is available in various sizes for different applications. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(540)832-5000orders@bossinst.com
+1(540)832-5000orders@bossinstruments.com

Regulatory Flags

DUNS number
848522678
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00888515231382BOSS Instruments90-7044P90-7044P2024-12-11
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