FDA.reportPublic FDA data

POLYESTER TAPE

Primary DI
00384401513124
Brand
POLYESTER TAPE
Company
INTERVASCULAR SAS
Model
Size 4.8mm x 76.2cm (3/16 in x 30 in)
Device description
Polyester Tape size 4.8mm x 76.2cm (3/16 in x 30 in) are commercially available only in multipack configuration (1 pair per pouch / 5 pouches per box) with the catalog number M002000194131.
Published
2017-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384401513216PackageGS15In Commercial Distribution
00384401513124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384401513216003844015132163844015132160384401513216
00384401513124003844015131243844015131240384401513124

GMDN Terms#

Term, Definition table
TermDefinition
Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature

Contacts#

Phone, Email table
PhoneEmail
+33442084646cardiovascular.vics@getinge.com

Regulatory Flags#

DUNS number
382174019
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00384401006466IntergardIGKUT0008RS15IGKUT0008RS152023-03-27
00384401007067IntergardIGKUT0006-20IGKUT0006-202023-03-27
00384401007609IntergardIGKUT0008-20IGKUT0008-202023-03-27
00384401009252IntergardIGKUT0007-20IGKUT0007-202023-03-27
00384401000013IntergardIGW0006-30IGW0006-302015-09-25
00384401000037IntergardIGW0008-30IGW0008-302015-09-25
00384401000051IntergardIGW0010-30IGW0010-302015-09-25
00384401000075IntergardIGW0012-15IGW0012-152015-09-25
00384401000082IntergardIGW0012-30IGW0012-302015-09-25
00384401000099IntergardIGW0014-15IGW0014-152015-09-25
00384401000105IntergardIGW0014-30IGW0014-302015-09-25
00384401000112IntergardIGW0016-15IGW0016-152015-09-25
00384401000129IntergardIGW0016-30IGW0016-302015-09-25
00384401000136IntergardIGW0018-15IGW0018-152015-09-25
00384401000143IntergardIGW0018-30IGW0018-302015-09-25
00384401000150IntergardIGW0020-15IGW0020-152015-09-25
00384401000167IntergardIGW0020-30IGW0020-302015-09-25
00384401000174IntergardIGW0022-15IGW0022-152015-09-25
00384401000181IntergardIGW0022-30IGW0022-302015-09-25
00384401000198IntergardIGW0024-15IGW0024-152015-09-25

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