FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963835682
Brand
AESCULAP
Company
B BRAUN SURGICAL SA
Model
1050071
Catalog number
1050071
Device description
HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
Published
2016-09-24
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
MPNTissue adhesive for the topical approximation of skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPNTissue Adhesive For The Topical Approximation Of SkinGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963656720PackageGS150Not in Commercial Distribution
04046963835682PrimaryGS10
04046963656713Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963656720040469636567204046963656720
04046963835682040469638356824046963835682
04046963656713040469636567134046963656713

GMDN Terms#

Term, Definition table
TermDefinition
Surgical internal adhesive/sealant, synthetic polymerA biodegradable synthetic polymer material [e.g., cyanoacrylate, poly glycerol sebacate arylate (PGSA)] intended to be used for internal surgical applications to bond a wide range of tissue types (e.g., bowel, liver, lung, vascular, urological) and might in addition be intended to achieve haemostasis through tissue sealing. It is applied using a disposable applicator (which may be included), and is intended to be fast-setting (self- or light-induced) to form a thin elastic film. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius22 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653915408SteelexC0992070C09920702015-08-16
04038653911097SteelexG0617814G06178142015-08-20
04038653713929DafilonC0933350C09333502015-08-16
04046963634421PremileneC2090607C20906072015-08-17
04038653819362CatgutB0560570B05605702015-08-05
04038653822324CatgutB0563978B05639782015-11-01
04038653844357PremicronC0026016C00260162015-08-06
04046963462376PremicronB0026409B00264092015-11-05
04038653707621DagrofilC0840130C08401302015-08-16
04038653708567DagrofilC0842273C08422732015-08-16
04038653735068DagrofilG0341215G03412152015-08-20
04038653735105DagrofilG0341231G03412312015-08-20
04038653735181DagrofilG0341274G03412742015-08-20
04038653750337PremicronM0027706M00277062015-08-26
04038653750399PremicronM0027736M00277362015-08-26
04038653750436PremicronM0027756M00277562015-08-26
04038653750450PremicronM0027766M00277662015-08-26
04038653798865DagrofilC0346659C03466592015-08-13
04038653828104DagrofilB0842648B08426482015-11-01
04038653866960DagrofilC0852210C08522102015-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08904255228672MERIGLUETM – Topical Skin AdhesiveMERIL ENDO SURGERY PRIVATE LIMITEDMPN2026-04-18
08904255228689MERIGLUETM – Topical Skin AdhesiveMERIL ENDO SURGERY PRIVATE LIMITEDMPN2026-04-18
00850081858102BondEaseOptmed IncMPN2026-03-20
00850081858003NaavaBondOptmed IncMPN2026-01-15
00854137001979exofin SCChemence Medical, Inc.MPN2024-06-20
10304040178857Henry ScheinHENRY SCHEIN, INC.MPN2024-01-12
00304040178850Henry ScheinHENRY SCHEIN, INC.MPN2024-01-12
05036912000758LiquiBand ButylADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001687LiquiBand ExceedADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001717LiquiBand Exceed XSADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001748LiquiBand Octyl MiniADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912000406LiquiBand ButylADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001694LiquiBand ExceedADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001724LiquiBand Exceed XSADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
05036912001755LiquiBand Octyl MiniADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LIMITEDMPN2023-06-12
20854137001140exofin HVTA ST&G, 1g Box of 10Chemence Medical, Inc.MPN2022-02-14
30854137001147exofin HVTA ST&G, 1g Box of 10CHEMENCE MEDICAL PRODUCTS, INC.MPN2022-02-14
00811220033521PremierProPRESTIGE AMERITECH, LTD.MPN2022-01-14
00811220033538PremierProSVS LLCMPN2022-01-14
00854137001658exofin Precision Pen Premier Pro, 1gChemence Medical, Inc.MPN2021-12-08
10854137001655Premier Pro Exofin Precision PenCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-12-08
00854137001634eXofin Precision Pen, 1gChemence Medical, Inc.MPN2021-11-10
00854137001641eXofin Precision Pen High Viscosity Topical Skin AdhesiveCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-11-10
00854137001672exofin HVTSA Premier Pro, 1gChemence Medical, Inc.MPN2021-11-08
10854137001679Premier Pro Exofin HVTA CHEMENCE MEDICAL PRODUCTS, INC.MPN2021-11-08
00854137001627exofin HVTSA, 1gChemence Medical, Inc.MPN2021-10-29
10854137001624eXofin High Viscosity Topical Skin AdhesiveCHEMENCE MEDICAL PRODUCTS, INC.MPN2021-10-29
20854137001621exofin HVTSA, 1g- Box of 60Chemence Medical, Inc.MPN2021-10-29
10888277728608MedlineMEDLINE INDUSTRIES, INC.MPN2021-01-11