FDA.reportPublic FDA data

Novo Surgical

Primary DI
10842331118781
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
9100-01
Catalog number
9100-01
Device description
Ligation Clips, 120 clips per box (6 clips/cartridge, 20 cartridges/box), extra-large, red
Published
2016-09-23
Public version status
Update
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
FZPCLIP, IMPLANTABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111930000ACKERMANN EUROPCLIPAckermann Instrumente GmbH2011-11-08FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842331118781PrimaryGS10
00842331115394Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084233111878110842331118781
00842331115394008423311153948423311153940842331115394

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
120
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842331167867Novo Surgical Inc.E7335-20E7335-202022-11-13
00842331167874Novo Surgical Inc.E7335-28E7335-282022-11-13
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704936882WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936899WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936905WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936912WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936929WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936936WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936943WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936950WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936967WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936974WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936981WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704936998WECKTELEFLEX INCORPORATEDFZP2026-10-20
14026704935779WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935786WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935809WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935823WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935847WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704725424WECKTELEFLEX INCORPORATEDFZP2026-08-01
00198506092794ELMED INCORPORATEDELMED INCORPORATEDFZP2026-07-28
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18