FDA.report

Key Surgical Biopsy Forceps

Primary DI
00849771038832
Brand
Key Surgical Biopsy Forceps
Company
KEY SURGICAL, INC.
Model
EN10269AS
Device description
Swinging Biopsy Forceps, Alligator Cup with Spike, 2.4mm Diam, 1800mm L
Published
2020-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FCLForceps, Biopsy, Non-Electric

Product Code Classifications

CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849771038849PackageGS110In Commercial Distribution
10849771038846PackageGS110In Commercial Distribution
00849771038832PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849771038849008497710388498497710388490849771038849
1084977103884610849771038846
00849771038832008497710388328497710388320849771038832

GMDN Terms

TermDefinition
Flexible endoscopic biopsy forceps, reprocessedA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy) 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 single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

Sterilization Methods

Method

Contacts

PhoneEmail
8005417995regulatory@keysurgical.com
+1(800)541-7995regulatory@keysurgical.com

Regulatory Flags

DUNS number
604056226
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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