Polysorb

Primary DI
10884521181625
Brand
Polysorb
Company
Covidien LP
Model
160029
Catalog number
160029
Device description
Bone Punch
Published
2015-08-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961578000SUTURE ANCHORUnited States Surgical, A Division of Tyco Healthc1996-07-10JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521181625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452118162510884521181625

GMDN Terms#

Term, Definition table
TermDefinition
Bone punch, reusableA hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft (the upper part sliding along the lower part) which is joined to sprung (self-opening), pivoted, pistol grip handles. The working end terminates with a sharp, angled, cutting jaw that closes over an endpiece when the handles are squeezed together cutting through the bone. It is available in various sizes and designs (e.g., it can have upward or downward located jaws) and is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true

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