BX Series Reusable Biopsy Forceps

Primary DI
00666416130023
Brand
BX Series Reusable Biopsy Forceps
Company
Primed Instruments Inc
Model
BX100N
Catalog number
BX100N
Device description
Reusable biopsy forceps with oval fenestrated jaws and no needle. HIBC/UPN: M453BX100N0
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NONForceps, Biopsy, Non-Electric, Reprocessed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NONForceps, Biopsy, Non-Electric, ReprocessedGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00666416130023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00666416130023006664161300236664161300230666416130023

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, reusableA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Biopsy forceps should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Each device is individually packaged.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-877-565-0565info@primedinstruments.com

Regulatory Flags#

DUNS number
254491293
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

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