FDA.reportPublic FDA data

Callisto Single-Use Laryngoscopes

Primary DI
05055382851370
Brand
Callisto Single-Use Laryngoscopes
Company
TIMESCO HEALTHCARE LIMITED
Model
DS.3940.460.11
Device description
Callisto Compact Preloaded Disp Lary Hdle
Published
2023-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055382851363PrimaryGS10
05055382851370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055382851363050553828513635055382851363
05055382851370050553828513705055382851370

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope handle, single-useA clean, non-sterile, hand-held segment of a laryngoscope (i.e., non-endoscopic rigid type) designed to manipulate the laryngoscope blade during airway access and intubation. It is a cylindrical device that contains batteries/light-emitting cells to provide the energy/light for the airway-illuminating feature of the laryngoscope (e.g., small light bulb, fibreoptics), and can accommodate various blades. It is available in various sizes and may be magnetic resonance imaging (MRI) compatible. This is a single-use device; the batteries/light-emitting cells are intended to be removed for reuse before the device is discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441268297700info@timesco.com

Regulatory Flags#

DUNS number
896967197
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055382830467Surgical40.390.202023-06-20
05055382830474Surgical40.390.402023-06-20
05055382833055Surgical40.905.102023-06-20
05055382857662Single Use TourniquetsD80.1002023-09-26
05055382857679Single Use TourniquetsD80.2002023-09-26
05055382858263Single Use TourniquetsD80.1502023-09-26
15055382857669Single Use TourniquetsD80.1002023-09-26
15055382857676Single Use TourniquetsD80.2002023-09-26
15055382858260Single Use TourniquetsD80.1502023-09-26
05055382837596Dental530.700.25530.700.252023-07-11
05055382841234Dental575.200.25575.200.252023-07-11
05055382841258Dental575.225.25575.225.252023-07-11
05055382843115Dental625.500.25625.500.252023-07-11
05055382843344Dental635.600.25635.600.252023-07-11
05055382843368Dental640.325.25640.325.252023-07-11
05055382843382Dental640.325.50640.325.502023-07-11
05055382843429Dental640.335.50640.335.502023-07-11
05055382843443Dental640.340.25640.340.252023-07-11
05055382843450Dental640.350.25640.350.252023-07-11
05055382843474Dental640.400.25640.400.252023-07-11

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Primary DI, Brand, Company table
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06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
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06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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