FDA.reportPublic FDA data

SPIRO

Primary DI
07350061231077
Brand
SPIRO
Company
Fogless International AB
Model
705
Catalog number
705-10
Device description
SPIRO Tweezers
Published
2018-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350061231077PackageGS15In Commercial Distribution
07350061231060PrimaryGS10
07350061231312Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350061231077073500612310777350061231077
07350061231060073500612310607350061231060
07350061231312073500612313127350061231312

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for tissue manipulation. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is typically metallic and available in various sizes. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dark and dry environment at normal indoor room temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4636144100mail@fogless.se

Regulatory Flags#

DUNS number
356432815
Device count
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
07350061231220SPIRO730730-2K2018-03-31
07350061230353SPIROXXX2023-09-21
07350061231008SPIRO702702-2K; 702-5K;2018-03-31
07350061231046SPIRO703703-2K2018-03-31
07350061231121SPIRO710710-1K; 710-2K; 710-5K2018-03-31
07350061231152SPIRO710R710R-1K; 710R-2K; 710R-5K2018-03-31
07350061231183SPIRO711711-1K; 711-2K; 711-5K;2018-03-31
07350061231268SPIRO760760-1K; 760-1KF2018-03-31
07350061231350SPIRO 740740-25K; 740-100K2018-03-31
07350061231060SPIRO705705-102018-03-31
07350061231084SPIRO707707-102018-03-31
07350061231107SPIRO708708-102018-03-31
07350061231091SPIRO707707-102018-03-31
07350061231114SPIRO708708-102018-03-31
07350061231237SPIRO730730-102018-03-31
07350061231282SPIRO7707702018-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07
B382SD9238971100Surgical DirectSurgical Direct, Inc.GEN2026-08-07
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422721MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422769MillenniumAvalign Technologies, Inc.GEN2026-08-03
00190776422790MillenniumAvalign Technologies, Inc.GEN2026-08-03
B382SD4829170Surgical DirectSurgical Direct, Inc.GEN2026-08-03
00190776422141MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422226MillenniumAvalign Technologies, Inc.GEN2026-07-31
00190776422233MillenniumAvalign Technologies, Inc.GEN2026-07-31
B382SD1426525010Surgical DirectSurgical Direct, Inc.GEN2026-07-31
B382SD1426525020Surgical DirectSurgical Direct, Inc.GEN2026-07-31
00810143904840SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904857SURGIPROSSurgipros, LLCGEN2026-07-30
00810143904864SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909227SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909715SURGIPROSSurgipros, LLCGEN2026-07-30
00810143909746SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934860SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934877SURGIPROSSurgipros, LLCGEN2026-07-30
00810212934884SURGIPROSSurgipros, LLCGEN2026-07-30