FDA.reportPublic FDA data

Saber®Bulb Evacuators

Primary DI
00840113224746
Brand
Saber®Bulb Evacuators
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
310101
Device description
Intended used for closed wound suction drainage
Published
2021-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840113224746PackageGS110In Commercial Distribution
00840113224739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840113224746008401132247468401132247460840113224746
00840113224739008401132247398401132247390840113224739

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(616)698-7100customerservice@aspensurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814707023817Protek1-519-1028B2026-02-16
00840113231867Bard-ParkerST-1002026-02-15
00887482023389Symmetry53-16622026-02-15
00887482023396Symmetry53-16632026-02-15
00887482023402Symmetry53-16642026-02-15
00887482138373Sterion10-00-752026-02-15
00887482156186Symmetry53-1662T2026-02-15
00887482156223Symmetry53-1664T2026-02-15
20887482023376Symmetry53-16612026-02-15
10607151000100BOVIE001000102016-10-10
10607151000117BOVIE001100112016-10-10
10607151000124BOVIE001200122016-10-10
10607151001428BOVIEA1204PA1204P2016-10-12
10607151001534BovieA802EUA802EU2016-10-19
10607151001541BOVIEA1252CA1252C2016-10-12
10607151001589BovieA1255AA1255A2016-09-28
10607151002258BovieNLOTNLOT2017-02-10
10607151002579BOVIEA1254CA1254C2016-10-12
10607151004733BOVIEA1202A12022016-10-12
10607151004801BovieFSSEPFSSEP2016-09-16

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Primary DI, Brand, Company table
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10840306831048Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
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