FDA.reportPublic FDA data

Pilling

Primary DI
04026704507023
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN002327
Catalog number
065166
Device description
MINI WECK APPROXIMATOR 5MM X 1.0MM BLADES
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCCLAMP, VASCULAR
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K861924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K861924000MICRO ANASTOMOSIS CLAMPPilling Co.1986-06-06DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704507023Direct MarkingGS10
24026704507027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704507023040267045070234026704507023
2402670450702724026704507027

GMDN Terms#

Term, Definition table
TermDefinition
Artery clampA hand-held manual surgical instrument designed for the temporary, atraumatic compression of an artery for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and designs of the working end are specific to the surgical application. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Width0.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
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
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
07898789390053KAYE FREEMAN FACE-LIFT SCISSORS CURVED 23CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDALRW2026-06-09
00810055251520Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810055251537Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450714Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450721Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450738Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450752Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450998Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451018Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451032Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451056Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451070Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451513Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451568Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451728Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451735Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810220800317Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800331Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
00810220800355Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800362Adler Instrument CompanyAdler, Inc.LRW2026-06-02
09348811115461INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-06-02
00810143908329SURGIPROSSurgipros, LLCLRW2026-06-01
00810212930688SURGIPROSSurgipros, LLCLRW2026-06-01
B356BK211110American MedicalsAmerican MedicalsLRW2026-05-29
00846159039702SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039719SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039726SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039733SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27