FDA.reportPublic FDA data

MANTA

Primary DI
00856279007369
Brand
MANTA
Company
ESSENTIAL MEDICAL, INC.
Model
IPN928169
Catalog number
114F
Device description
MANTA 14F Depth Locator
Published
2023-10-23
Public version status
New
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
MGBDevice, Hemostasis, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGBDevice, Hemostasis, VascularUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856279007366PackageGS15In Commercial Distribution
00856279007369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085627900736610856279007366
00856279007369008562790073698562790073690856279007369

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery closure plug/patch, collagenAn implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French

Contacts#

Phone, Email table
PhoneEmail
866-246-6990cs@teleflex.com

Regulatory Flags#

DUNS number
013273872
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856279007307MANTAIPN92816621152023-10-23
00856279007321MANTAIPN92816721562023-10-23
00856279007345MANTAIPN928168188F2023-10-23
10856279007304MANTAIPN92816621152023-10-23
10856279007328MANTAIPN92816721562023-10-23
10856279007342MANTAIPN928168188F2023-10-23
10856279007366MANTAIPN928169114F2023-10-23
00856279007208MANTA 14F Depth Locator114F2021-06-30
00856279007215MANTA 14F Depth Locator114F2021-06-30
00856279007246MANTA 8F Depth Locator188F2020-05-21
00856279007062MANTA21152019-02-08
00856279007079MANTA21562019-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M7298001014XL0VASCADE MVP XL VVCSCARDIVA MEDICAL, INC.MGB2026-05-18
10841156111335MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111359MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111373MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156103439D-STATTELEFLEX INCORPORATEDMGB2025-07-16
20841156103436D-STATTELEFLEX INCORPORATEDMGB2025-07-16
05391530280617Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FVASORUM LIMITEDMGB2025-04-24
10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109929MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109936MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109950MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109902MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109926MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109933MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109957MANTATELEFLEX INCORPORATEDMGB2024-09-09
10705032090278MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
20705032090275MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
10841156109080D-STATTELEFLEX INCORPORATEDMGB2023-12-11
20841156109087D-STATTELEFLEX INCORPORATEDMGB2023-12-11
00856279007307MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007321MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007345MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
10856279007304MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23