NA

Primary DI
10888551001496
Brand
NA
Company
STERILMED, INC.
Model
MIC1012
Catalog number
MIC1012
Device description
BIOPSY FORCEPS COLD MULTIBITE MULTIPLE SAMPLE (ORANGE)
Published
2020-09-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042648000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042648000REPROCESSED COLD BIOPSY FORCEPSSterilmed, Inc.2005-07-20NON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551001496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855100149610888551001496

GMDN Terms#

Term, Definition table
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 table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551035224NASTR1608-2-111608-2-112018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15
10888551045414NASYN03.312.590SYN03.312.5902019-11-15
10888551045421NASYN03.312.350SYN03.312.3502019-11-15
10888551045438NASYN03.312.380SYN03.312.3802019-11-15
10888551045445NASYN03.312.410SYN03.312.4102019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M453BX910N0BX Series Multi-Sampling Reusable Biopsy ForcepsPrimed Instruments IncNON2021-02-26
10888551001540NASTERILMED, INC.NON2020-09-06
10888551001557NASTERILMED, INC.NON2020-09-06
10888551001564NASTERILMED, INC.NON2020-09-06
10888551001571NASTERILMED, INC.NON2020-09-06
10888551001588NASTERILMED, INC.NON2020-09-06
10888551001595NASTERILMED, INC.NON2020-09-06
10888551001601NASTERILMED, INC.NON2020-09-06
10888551001618NASTERILMED, INC.NON2020-09-06
10888551001625NASTERILMED, INC.NON2020-09-06
10888551001632NASTERILMED, INC.NON2020-09-06
10888551001670NASTERILMED, INC.NON2020-09-06
10888551001687NASTERILMED, INC.NON2020-09-06
10888551001694NASTERILMED, INC.NON2020-09-06
10888551001700NASTERILMED, INC.NON2020-09-06
10888551001724NASTERILMED, INC.NON2020-09-06
10888551001731NASTERILMED, INC.NON2020-09-06
10888551001748NASTERILMED, INC.NON2020-09-06
10888551001755NASTERILMED, INC.NON2020-09-06
10888551001762NASTERILMED, INC.NON2020-09-06
10888551013420NASTERILMED, INC.NON2020-09-06
10888551013437NASTERILMED, INC.NON2020-09-06
10888551013444NASTERILMED, INC.NON2020-09-06
10888551013451NASTERILMED, INC.NON2020-09-06
10888551013468NASTERILMED, INC.NON2020-09-06
10888551013475NASTERILMED, INC.NON2020-09-06
00666416130016BX Series Reusable Biopsy ForcepsPrimed Instruments IncNON2017-10-23
00666416130023BX Series Reusable Biopsy ForcepsPrimed Instruments IncNON2017-10-23
00666416130030BX Series Reusable Biopsy ForcepsPrimed Instruments IncNON2017-10-23
00666416130047BX Series Reusable Biopsy ForcepsPrimed Instruments IncNON2017-10-23