PyroCarbon PIP Total Joint System

Primary DI
00885556858400
Brand
PyroCarbon PIP Total Joint System
Company
Smith & Nephew, Inc.
Model
PIP-200-10P-WW
Catalog number
PIP-200-10P-WW
Device description
PIP SZ. 10 PROXIMAL
Published
2023-02-10
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
OMXHigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMXHigh Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger ProsthesisUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H010005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H010005000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556858400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556858400008855568584008855568584000885556858400

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, reusableA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556858394PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858417PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858424PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858431PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858448PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858455PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
00885556858462PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.OMX2023-02-10
10381780000464Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000471Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000488Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000495Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000501Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000518Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000525Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
10381780000532Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040PWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20010DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20020DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20030DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18
M269PIP20040DWW1Ascension PIPAscension Orthopedics, Inc.OMX2014-09-18