FDA.reportPublic FDA data

PERCUVANCE

Primary DI
14026704640208
Brand
PERCUVANCE
Company
TELEFLEX INCORPORATED
Model
IPN029181
Catalog number
PCVSB12
Device description
12 MILLIMETER SEAL BRIDGE
Published
2018-10-22
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
GEIElectrosurgical, cutting & coagulation & accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181852000Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.2018-10-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704640202PackageGS16Not in Commercial Distribution
44026704640209PackageGS16Not in Commercial Distribution
14026704582881PreviousGS10
14026704640208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670464020234026704640202
4402670464020944026704640209
1402670458288114026704582881
1402670464020814026704640208

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic access cannula seal reducer, single-useA small device intended to reduce the sealing diameter of an existing laparoscopic access cannula seal, so laparoscopic instruments with smaller diameters can be introduced through the parent laparoscopic sleeve whilst maintaining a seal and inhibiting the leakage of insufflation media [e.g., carbon dioxide (CO2) gas]. It is intended to fit within the laparoscopic access cannula seal (fitted at the proximal end of the cannula) when required throughout the laparoscopic surgical procedure. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.4Inch
Width0.7Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature16 Degrees Celsius37 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801902002266ARROWIPN000082AI-071342016-09-16
00801902003362ARROWIPN035388CC-017002026-08-03
00850921007417ARROWIPN919634DLX-200-USC2026-08-03
04026704916955RUSCHIPN9007315640002026-08-03
04026704934812TELEFLEXIPN931133ST192026-08-03
05060112310058LMA AIRWAY MANAGEMENTIPN9016471000152026-08-03
05060112310065LMA AIRWAY MANAGEMENTIPN9016491000202026-08-03
05060112310607LMA AIRWAY MANAGEMENTIPN9018611500152026-08-03
10801902170191ARROWIPN917307CS-017012026-08-03
10801902206241ARROWIPN922981PW-18080-HS2026-08-03
10801902215168ARROWIPN9280309001T-VC-0052026-08-03
10801902219210ARROWIPN929382CV-15123-F2026-08-03
10801902226416ARROWIPNB00521ASK-21242-UR32026-08-03
14026704730466PILLINGIPN924356P358PRA2026-08-03
14026704934758LMA AIRWAY MANAGEMENTIPN9292541360652026-08-03
14026704934765LMA AIRWAY MANAGEMENTIPN9292561360752026-08-03
14026704934772LMA AIRWAY MANAGEMENTIPN9292571360802026-08-03
14026704934802LMA AIRWAY MANAGEMENTIPN9292551360702026-08-03
00801902004857ARROWIPN033843AK-040202016-09-16
05060112310041LMA AIRWAY MANAGEMENTIPN9016451000102026-07-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28