FDA.reportPublic FDA data

Sterishot II Kit

Primary DI
15055515602333
Brand
Sterishot II Kit
Company
FEMCARE LIMITED
Model
AVM-951
Catalog number
AVM-951
Device description
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator and one pair of Filshie® Clips.
Published
2019-02-01
Public version status
Update
Distribution status
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
KNHDevice, Occlusion, Tubal, Contraceptive

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P920046008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P920046008FILSHIE CLIP (MARK VI) SYSTEMFemcare , Ltd.1996-09-05KNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
45055515602334PackageGS110In Commercial Distribution
55055515602331PackageGS114Not in Commercial Distribution
15055515602180PreviousGS10
15055515602333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4505551560233445055515602334
5505551560233155055515602331
1505551560218015055515602180
1505551560233315055515602333

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

Contacts#

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

Regulatory Flags#

DUNS number
500218573
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
05055515602121Filshie® ClipsAVM-851AVM-8512014-09-25

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
15055515602357Sterishot (Femcare) for MinilaparotomyFEMCARE LIMITEDKNH2019-02-01
25055515602194SterishotFEMCARE LIMITEDKNH2018-12-06
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