NA

Primary DI
10888551007955
Brand
NA
Company
STERILMED, INC.
Model
COODBF-2.4-230SP-S
Catalog number
COODBF-2.4-230SP-S
Device description
BIOPSY FORCEPS CAPTURA WITH SPIKE 2.8MM WORKING CHANNEL (RED)
Published
2016-09-22
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
10888551007955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855100795510888551007955

GMDN Terms#

Term, Definition table
TermDefinition
Female wearable urinal, reusableA non-sterile, urine drainage device designed for women that typically consists of a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+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
10888551001496NASTERILMED, INC.NON2020-09-06
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