FDA.reportPublic FDA data

Sterishot

Primary DI
25055515602194
Brand
Sterishot
Company
FEMCARE LIMITED
Model
Minilap - Kit
Catalog number
AVM-951M
Device description
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
Published
2018-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNHDevice, Occlusion, Tubal, Contraceptive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNHLaparoscopic Contraceptive Tubal Occlusion DeviceObstetrics/Gynecology3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920046010

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920046010FILSHIE CLIP (MARK VI) SYSTEMFemcare , Ltd.1996-09-05KNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25055515602194PackageGS110In Commercial Distribution
15055515602197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2505551560219425055515602194
1505551560219715055515602197

GMDN Terms#

Term, Definition table
TermDefinition
Fallopian tube clip/bandAn implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441794525100enquiries@femcare.co.uk

Regulatory Flags#

DUNS number
500218573
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15055515602241Filshie® Clips (Femcare)AVM-851JAVM-851J2019-02-01
25055515602248Filshie® Clips (Femcare)AVM-851JAVM-851J2025-02-28
25055515602262Filshie® ClipsAVM-851SCAVM-851SC2025-02-28
05055515602244Filshie® Clips (Femcare)AVM-851JAVM-851J2025-02-28
05055515602169Filshie® Clip Applicator, Minilap (CSI)AVM-856AVM-8562014-09-25
15055515602234Filshie® Clips (Femcare)AVM-851AVM-8512019-02-01
15055515602333Sterishot II KitAVM-951AVM-9512019-02-01
15055515602180Sterishot II Kit (CSI)AVM-951AVM-9512017-06-21
15055515602197Sterishot Kit for Minilaparotomy (CSI)AVM-951MAVM-951M2018-12-06
15055515600261No-Scalpel Vasectomy3.5mm clampLV-3CL-8572023-06-07
15055515600278No-Scalpel Vasectomy3.5mm KitLV-03K-8562023-06-07
15055515600285No-Scalpel VasectomyForcepsLV-FCP-8582023-06-07
15055515600292No-Scalpel Vasectomy4.0mm kitLV-04K-8592023-06-07
15055515600308No-Scalpel Vasectomy4.0mm Ring ClampLV-4CL-8602023-06-07
15055515602265Filshie® ClipsAVM-851SCAVM-851SC2023-05-15
05055515602268Filshie® ClipsAVM-851SCAVM-851SC2023-05-15
15055515602326SterishotAVM-600AVM-6002023-05-15
15055515602340Sterishot (Femcare) for MinilaparotomyAVM-600MAVM-600M2023-05-15
15055515600759SterishotIIFE-7SS-6002016-12-21
05055515602114Filshie® ClipsAVM-851JAVM-851J2017-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
25055515602248Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2025-02-28
25055515602262Filshie® ClipsFEMCARE LIMITEDKNH2025-02-28
05055515602244Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2025-02-28
00821925028869FALOPE-RINGGyrus ACMI, LLCKNH2024-07-12
00821925028913Gyrus ACMIGyrus ACMI, LLCKNH2024-07-12
15055515602265Filshie® ClipsFEMCARE LIMITEDKNH2023-05-15
05055515602268Filshie® ClipsFEMCARE LIMITEDKNH2023-05-15
15055515602326SterishotFEMCARE LIMITEDKNH2023-05-15
15055515602340Sterishot (Femcare) for MinilaparotomyFEMCARE LIMITEDKNH2023-05-15
00868029000391Head Coil (Receive Only)VIEWRAY INCORPORATEDKNH2022-05-06
15055515602371Sterishot II Elite KitFEMCARE LIMITEDKNH2021-01-14
15055515602234Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602241Filshie® Clips (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602272Filshie® Clip Applicator, Minilap (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602289Filshie® Clip Applicator, 7.3mm SI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602296Filshie® Clip Applicator, 7mm DI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602302Filshie® Clip Applicator, 5mm SI (Femcare)FEMCARE LIMITEDKNH2019-02-01
15055515602333Sterishot II KitFEMCARE LIMITEDKNH2019-02-01
15055515602357Sterishot (Femcare) for MinilaparotomyFEMCARE LIMITEDKNH2019-02-01
15055515602197Sterishot Kit for Minilaparotomy (CSI)FEMCARE LIMITEDKNH2018-12-06
05055515602114Filshie® ClipsFEMCARE LIMITEDKNH2017-06-22
25055515602187SterishotFEMCARE LIMITEDKNH2017-06-21
15055515602180Sterishot II Kit (CSI)FEMCARE LIMITEDKNH2017-06-21
00821925000186Gyrus ACMIGyrus ACMI, LLCKNH2017-05-08
15055515600759SterishotFEMCARE LIMITEDKNH2016-12-21
25055515600756SterishotFEMCARE LIMITEDKNH2016-12-21
00821925028852FALOPE RING Gyrus ACMI, LLCKNH2016-10-07
00861523000102Hulka ClipsRICHARD WOLF MEDICAL INSTRUMENTS CORP.KNH2014-11-11
05055515602121Filshie® ClipsFEMCARE LIMITEDKNH2014-09-25
05055515602138Filshie® Clip Applicator, 5mm SIFEMCARE LIMITEDKNH2014-09-25